Flight Dental Systems Clave16+

• FDA 510(k) K243994 decided 6 Jun 2025 Active
• FDA GUDID UDI-DI D178CLAVE16 listed 18 Jul 2025 Listed

1. 6 Jun 2025 Cleared FDA 510(k) K243994
2. 18 Jul 2025 Listed FDA GUDID D178CLAVE16

Trade name

Flight Dental Systems

Generic name

Steam sterilizer

Model / Ref / Catalog

Clave16+

Primary DI / UDI-DI

D178CLAVE16

510(k) Number

K243994 ↗

FDA product code

FLE

GMDN term

Steam sterilizer

Device class

Class II

Regulation number

880.6880

GUDID distribution status

In Commercial Distribution

Category: Steam sterilizer

Other devices filed under FDA product code FLE (Sterilizer, Steam).

• STERILIZER, SERIES 3000, MODIFICATION TO by Castle Co.
• EASTERCLAVE by Easter Services, Inc.
• BELIMED STEAM STERILIZER, MODEL TOP 5000 by Sauter AG
• TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HA by Tuttnauer Co., Ltd.
• STARCRAFT ELITE AUTOCLAVE by Starcraft Medical Corp.
• MODIFIED CASTLE POWERCLAVE by Castle Co.
• REBUILDING STERILIZERS by Mdt Corp., Inc.
• Belimed Steam Sterilizer MST-H TOP 5000 by Belimed AG
• Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS by Tuttnauer Co., Ltd.
• BELIMED STEAM STERILIZER, MODEL MST-V 3-3-6 by Belimed Sauter AG

• Flight Dental Systems Clave8+

  Class II

  FDA 510(k) K243994 Active Cleared 6 Jun 2025 GUDID on market

• Flight Dental Systems A6EP-102

  Class I

  FDA 510(k) K070196 Active Cleared 26 Jan 2007 GUDID on market

• Flight Dental Systems A6EP-100

  Class I

  FDA 510(k) K070196 Active Cleared 26 Jan 2007 GUDID on market

• Flight Dental Systems QC-165K

  Class I

  FDA 510(k) K181691 Active Cleared 26 May 2020 GUDID on market

See all devices from Flight Dental Systems USA Inc. →